General information. Name: Colin Sainsbury

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1 General information Name of Organisation ByrneWallace Contact information Head of Organisation Main contact Name: Catherine Guy (Managing Partner) Address: 88 Harcourt Street, Dublin 2 Telephone: Fax: cguy@byrnewallace.com Name: Colin Sainsbury Address: 88 Harcourt Street, Dublin 2 Telephone: Fax: csainsbury@byrnewallace.com Web Site: Life Sciences Brochure attached LIFE SCIENCES ByrneWallace's life sciences team is a multi-disciplinary practice group, successfully combining the very best of the firm s transactional, regulatory, competition and intellectual property expertise to serve the pharmaceutical, biotechnology, medical devices and diagnostic industries in Ireland. We provide legal business services to all types of enterprises active in the life sciences industry. Our clients range from the earliest stage university spin-out companies, to established later stage indigenous companies and global pharmaceutical, biotech and medical device and clinical research organisations. We also act for venture capital and private equity funds investing in the Irish life sciences industry, research institutions, and companies involved in the establishment and provision of healthcare services. The Life Sciences group have particular expertise in advising in relation to clinical trial agreements both from the perspective of the service provider and the pharma, biotech and medical device customer. The specialist skill sets we have assembled, together with real industry and regulatory experience and a dedicated approach to serving the life sciences industry, enables us to provide the highest quality legal service in a focused manner. Page 1 of 5

2 Two members of the Life Sciences team held senior in-house legal roles at Elan Corporation and Amarin Corporation. The life sciences team draws on the specialist skills and technical expertise of lawyers from the firm s corporate and commercial, regulatory, intellectual property, tax, product liability, EU and competition, projects and construction and other specialist practice areas. We pool our diverse and complementary skills in an integrated, practical and innovative manner according to client needs. This dynamic and flexible approach has enabled us to develop and maintain a leading position in the provision of focused advice to life sciences companies. Focus of our service Licensing, research and development and other industry commercialisation agreements Venture capital, private equity and other fundraising structures Regulatory issues Structuring and negotiation of complex sectoral specific transactions Contentious and non-contentious intellectual property Clinical trial agreements Product liability EU and Irish competition issues, including parallel importing issues Environmental issues Transfer pricing and other taxation issues Projects and construction Data protection Life science and pharmaceutical regulatory law Conduct of clinical trials EU and irish medicine law Company formations and company secretarial services Mergers, acquisitions, restructurings, joint ventures and other corporate transactions Healthcare Services Page 2 of 5

3 Experience in EU, FDA and other markets. Representative transactions include: Advising Alimentary Health on a number of transactions, including agreements with Mead Johnson, Procter & Gamble and Norgine Advising Azur Pharma on product acquisitions and commercialisation transactions, including the acquisitions of FazaClo and Prialt, and the merger between Azur and Jazz Pharmaceuticals Advise Biogen Idec on various issues involving reimbursement and market access in Ireland Advising Dignity Sciences on all legal matters relating to its establishment and various development stage agreements, including master services agreements and clinical agreements Advising Elan Corporation on various transactions, including a strategic alliance with Eli Lilly, and licensing transactions with Abbott Laboratories, AstraZeneca and MAP and the merger of Elan Drug Technologies with Alkermes Advise the vendors in the sale of Firecrest Clinical to Icon plc Advising i360 Medical on its establishment and early stage financing and industry agreements Advising Merrion Pharmaceuticals on its IEX flotation, and various other transactions, including two $58m licence agreements with Novo Nordisk Advising Java Clinical in relation to clinical trial agreements Advised on the sale of Newport Pharmaceuticals Limited to Ewopharma A.G. Advising Opsona Therapeutics on various matters, including its Phase I clinical trial and proposed Phase II clinical trial and the spin-out of Trimod Therapeutics Advising Astellas in relation a number of its clinical trial agreements Advising Firecrest Clinical in relation to a number of its agreements with Life Sciences companies Advising Beaumont Hospital in relation to a number of clinical trial agreements. Regularly advising our Life Sciences clients in relation to data protection legislation and related issues Please see our Life Sciences Brochure for further details of our experience and our Life Sciences Team ( Page 3 of 5

4 HEALTH SERVICES ByrneWallace is also one of the most experienced providers of legal healthcare services in Ireland. Our multidisciplinary Healthcare Services Group advises a broad spectrum of clients on a diverse range of issues in the healthcare sector, including the following: Risk Management We have provided advice to hospitals in relation to the management of adverse incidents and the development of policies and procedures to offset the risk of such incidents, such as standards for infection control and the management of complaints; Capacity and Consent We have provided advice to hospitals and healthcare providers on a broad range of complex issues pertaining to patient capacity and consent. For example, we have advised upon the issue of patient consent in the context of the testing of blood samples for blood borne viruses. In addition, we have provided advice in relation to consent issues regarding the use of human tissue obtained from research subjects; Confidentiality and Disclosure We have provided comprehensive advices in relation to issues concerning patient confidentiality and the disclosure of medical records, to include the position both at common law and under Irish Statute as provided for by the Data Protection Acts and the Freedom of Information Acts; Public Administrative Law We have advised clients on an extensive range of public administrative law issues, including representing the Health Service Executive in over 25 cases in the High Court taken under Article 40 of the Constitution relating to alleged unlawful detention under the Mental Health Legislation. We also represented a private Fertility Clinic in the frozen embryo case where the public law issues to be determined by the High Court concerned the right to life and the status of the embryo. We have also acted for the Health Service Executive in applications to the High Court for permissive orders in both the clinical and mental health context; Service Level Agreements We have drafted Service Level Agreements and advised the Health Service Executive in relation to the contracting of private hospital services and rapid access services. We have also advised the Health Service Executive on a national level on the contracting of private nursing home services. In addition, we have advised on and reviewed draft agreements in areas relating to clinical waste management and the supply and storage of blood and blood products. Page 4 of 5

5 Regulatory Compliance - We advise and represent the HSE in relation to regulatory compliance in such areas as food hygiene, nursing homes, creches and tobacco legislation; Professional Standards We have provided advice to healthcare service providers on issues arising under the Medical Practitioners Acts and the Nurses Acts. Inquiries and Investigations We have advised the Health Service Executive in relation to the conduct of internal inquiries and investigations to ensure that witnesses are correctly managed and fair procedures are followed. In addition, we have been involved in some of the most comprehensive and high profile investigations and inquiries over the last 30 years - for example, the Lourdes Inquiry, Irish Blood Transfusion Service (Lindsay), Brothers of Charity, McElwee, Cavan Hospital and the Commission of Investigation into Child Sexual Abuse and the Commission of Investigation into Leas Cross Nursing Home. Hospital Deaths and Inquests We have advised hospitals in relation to any legal issues arising from hospital deaths and we have represented the Health Service Executive at inquests in the Coroner s Court. Training We have provided extensive training to all of our healthcare clients, including the hosting of workshops, the delivery of on-site talks or seminars and the hosting of conferences in relation to various aspects of healthcare law. Please see the attached document with details of some members of our Health Services Team. Page 5 of 5